K-number	DEN190043
Device name	SafeBreak Vascular
Applicant	Site Saver, Inc. D/B/A Lineus Medical
Product code	QOI
Device class	Class II
Decision date	May 27, 2021
Decision	Not Substantially Equivalent
Regulation	880.5220

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Source

View the full FDA submission: accessdata.fda.gov

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SafeBreak Vascular

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